Over 20 percent of the 400 million diabetic patients all around the world have foot ulcers. Foot ulcers can be caused by loss of circulation and sensitivity of the skin on the foot, consequently leading to its embrittlement and vulnerability to cracking. The most common sites for occurrence of a foot ulcer are the high pressure points namely the toes, metatarsals, arch, and the heel. An offloading boot can be used to walk with a toe ulcer, as it redistributes the foot pressure onto the heel with minimal pressure transmitted to the toe. However, often, excessive heel pressure may cause the development of heel ulcers. The only technology available in the market for heel ulcers is a total contact cast (TCC) or a plaster. TCC's are also used for toe ulcers that get worse (in terms of size and healing) with time. In some cases, ulcers are also observed at the arch of the foot, which can also be covered using a TCC. The most common issues with both the offloading boot and the TCC are reduced mobility, the requirement of wound dressing on a daily or weekly basis, and slow wound healing (due to all time encapsulation of the ulcers and no contact with the atmosphere). If not taken care of, the ulcers can require a foot amputation. The current treatment for foot ulcers is the V.A.C (Vacuum Assisted Closure), in which the patient must either sit in a wheelchair or is confined to bed rest. Currently, patients with foot ulcers have no way to continue leading their normal life, go to work, socialize or perform their regular activities. Also, besides physical trauma, there is a huge amount of mental trauma which these patients often go through.
Current products focus on prevention of diabetic ulcers rather than their cure and management. The technologies invented for the treatment of diabetic ulcers were mostly in the form of bandages and protective ulcer enclosures which hinders patient mobility. Ulcer isolation has been explored in combination with a TCC, however, the drawbacks associated with TCC persist.
There remains a need for improved footwear for diabetic patients. There remains a need for readily available insoles capable of preventing and/or reducing the incident of foot ulcers. There remains a need for low cost, practical treatments of foot ulcers.